Method and apparatus for determining relative positioning between neurostimulation leads

ABSTRACT

A method and medical system for operating two leads disposed adjacent tissue of a patient are provided. A first one of a pair of electrodes respectively carried by the two leads is activated to generate an electrical field within the tissue. An electrical parameter in response to the generated electrical field is measured at a second one of the pair of electrodes. A reference electrical parameter is measured in response to the generated electrical field at a reference electrode carried by the same one of the two leads that carries the first electrode. A reference distance between the first electrode and the reference electrode is known prior to the generation of the electrical field. The ratio between the measured electrical parameter and the measured reference electrical parameter is computed, and the distance between the pair of electrodes is computed as a function of the computed ratio and the reference distance.

RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 12/623,976, filed Nov. 23, 2009, now U.S. patent Ser. No.______, which claims the benefit under 35 U.S.C. §119 to U.S.provisional patent application Ser. No. 61/119,669, filed Dec. 3, 2008.The foregoing applications are expressly incorporated herein byreference.

FIELD OF THE INVENTION

The present invention relates to tissue stimulation systems, and moreparticularly, to apparatus and methods for positioning neurostimulationleads.

BACKGROUND OF THE INVENTION

Implantable neurostimulation systems have proven therapeutic in a widevariety of diseases and disorders. Pacemakers and Implantable CardiacDefibrillators (ICDs) have proven highly effective in the treatment of anumber of cardiac conditions (e.g., arrhythmias). Spinal CordStimulation (SCS) systems have long been accepted as a therapeuticmodality for the treatment of chronic pain syndromes, and theapplication of tissue stimulation has begun to expand to additionalapplications such as angina pectoralis and incontinence. Deep BrainStimulation (DBS) has also been applied therapeutically for well over adecade for the treatment of refractory chronic pain syndromes, and DBShas also recently been applied in additional areas such as movementdisorders and epilepsy. Further, in recent investigations PeripheralNerve Stimulation (PNS) systems have demonstrated efficacy in thetreatment of chronic pain syndromes and incontinence, and a number ofadditional applications are currently under investigation. Also,Functional Electrical Stimulation (FES) systems such as the Freehandsystem by NeuroControl (Cleveland, Ohio) have been applied to restoresome functionality to paralyzed extremities in spinal cord injurypatients.

Each of these implantable neurostimulation systems typically includesone or more stimulation leads implanted at the desired stimulation siteand an implantable neurostimulator, such as an implantable pulsegenerator (IPG), implanted remotely from the stimulation site, butcoupled either directly to the stimulation leads or indirectly to thestimulation leads via one or more lead extensions in cases where thelength of the stimulation leads is insufficient to reach the IPG. Thus,electrical pulses can be delivered from the neurostimulator to thestimulation leads to stimulate the tissue and provide the desiredefficacious therapy to the patient.

In the context of an SCS procedure, one or more stimulation leads areintroduced through the patient's back into the epidural space, such thatthe electrodes carried by the leads are arranged in a desired patternand spacing to create an electrode array. One type of commerciallyavailable stimulation leads is a percutaneous lead, which comprises acylindrical body with ring electrodes, and can be introduced intocontact with the affected spinal tissue through a Touhy-like needle,which passes through the skin, between the desired vertebrae, and intothe epidural space above the dura layer. For unilateral pain, apercutaneous lead is placed on the corresponding lateral side of thespinal cord. For bilateral pain, a percutaneous lead is placed down themidline of the spinal cord, or two or more percutaneous leads are placeddown the respective sides of the midline of the spinal cord, and if athird lead is used, down the midline of the special cord. After properplacement of the stimulation leads at the target area of the spinalcord, the leads are anchored in place at an exit site to preventmovement of the stimulation leads. To facilitate the location of theneurostimulator away from the exit point of the stimulation leads, leadextensions are sometimes used.

Whether lead extensions are used or not, the proximal ends of thestimulation leads exiting the spinal column are passed through a tunnelsubcutaneously formed along the torso of the patient to a subcutaneouspocket (typically made in the patient's abdominal or buttock area) wherea neurostimulator is implanted. The subcutaneous tunnel can be formedusing a tunneling tool over which a tunneling straw may be threaded. Thetunneling tool can be removed, the stimulation leads threaded throughthe tunneling straw, and then the tunneling straw removed from thetunnel while maintaining the stimulation leads in place within thetunnel.

The stimulation leads are then connected directly to the neurostimulatorby inserting the proximal ends of the stimulation leads within one ormore connector ports of the IPG or connected to lead extensions, whichare then inserted into the connector ports of the IPG. The IPG can thenbe operated to generate electrical pulses that are delivered, throughthe electrodes, to the targeted tissue, and in particular, the dorsalcolumn and dorsal root fibers within the spinal cord.

The stimulation creates the sensation known as paresthesia, which can becharacterized as an alternative sensation that replaces the pain signalssensed by the patient. Intra-operatively (i.e., during the surgicalprocedure), the neurostimulator may be operated to test the effect ofstimulation and adjust the parameters of the stimulation for optimalpain relief. The patient may provide verbal feedback regarding thepresence of paresthesia over the pain area, and based on this feedback,the lead positions may be adjusted and re-anchored if necessary. Acomputerized programming system, such as Bionic Navigator®, availablefrom Boston Scientific Neuromodulation Corporation, can be used tofacilitate selection of the stimulation parameters. Any incisions arethen closed to fully implant the system. Post-operatively (i.e., afterthe surgical procedure has been completed), a clinician can adjust thestimulation parameters using the computerized programming system tore-optimize the therapy.

The efficacy of SCS is related to the ability to stimulate the spinalcord tissue corresponding to evoked paresthesia in the region of thebody where the patient experiences pain. Thus, the working clinicalparadigm is that achievement of an effective result from SCS depends onthe neurostimulation lead or leads being placed in a location (bothlongitudinal and lateral) relative to the spinal tissue such that theelectrical stimulation will induce paresthesia located in approximatelythe same place in the patient's body as the pain (i.e., the target oftreatment). If a lead is not correctly positioned, it is possible thatthe patient will receive little or no benefit from an implanted SCSsystem. Thus, correct lead placement can mean the difference betweeneffective and ineffective pain therapy.

Multi-lead configurations have been increasingly used in electricalstimulation applications (e.g., neurostimulation, cardiacresynchronization therapy, etc.). In the neurostimulation application ofSCS, the use of multiple leads increases the stimulation area andpenetration depth (therefore coverage), as well as enables morecombinations of anodic and cathodic electrodes for stimulation, such astransverse multipolar (bipolar, tripolar, or quadra-polar) stimulation,in addition to any longitudinal single lead configuration.

Several studies have demonstrated the advantage of using narrowlyspaced, parallel leads placed symmetrically on both sides of thephysiological midline in improving penetration and paresthesia coverage(see J. J. Struijk and J. Holsheimer Tripolar Spinal Cord Stimulation:Theoretical Performance of a Dual Channel System, Medical and BiologicalEngineering and Computing, Vol. 34, No. 4, 1996, pp. 273-279; J.Holsheimer, B. Nuttin, G. King, W. Wesselink, J. Gybels, and P. deSutter, Clinical Evaluation of Paresthesia Steering with a New Systemfor Spinal Cord Stimulation, Neurosurgery, Vol. 42, No. 3, 1998, pp.541-549; Holsheimer J., Wesselink, W. A., Optimum Electrode Geometry forSpinal Cord Stimulation: the Narrow Bipole and Tripole, Medical andBiological Engineering and Computing, Vol. 35, 1997, pp. 493-497).

For example, to produce the feeling of paresthesia without inducingdiscomfort or involuntary motor movements within the patient, it isoften desirable to preferentially stimulate nerve fibers in the dorsalcolumn (DC) nerve fibers, which primarily include sensory nerve fibers,over nerve fibers in the dorsal root (DR) nerve fibers, which includeboth sensory nerve fibers and motor reflex nerve fibers. In order tostimulate the DC nerve fibers, while guarding against the stimulation ofthe DR nerve fibers, a transverse tripolar lead arrangement may activateanodes that flank a single cathode in a medial-lateral electrical field,with the single cathode providing the stimulation energy for the DCfibers, while the flanking anodes guarding against the over-stimulationof the DR fibers, thereby increasing the therapeutic range of SCS forstimulating the desired DC fibers, while reducing the unwanted sideeffect of stimulating DR fibers

Thus, in a multi-lead system, more particularly a system using multiplepercutaneous leads, it is desired that two or more leads are placedparallel in close proximity to each other. During the lead implantation,the leads are placed closely at the surgeon's best effort. Fluoroscopyimages are usually acquired after lead insertion to verify the placementand proximity of the leads, and a revision/correction can be made ifnecessary. Since the leads are ultimately placed in three-dimensionalspace, two-dimensional fluoroscopic views (e.g., in the context of SCS,an anteroposterior (AP) view and a lateral view) are used to check thelead proximity.

However, fluoroscopic imaging requires a bulky instrument, which limitsits use in the operating room. Thus, sometimes, only an AP view isacquired, while a lateral view is optional and its acquisition dependson the preference of the surgeon. When only an AP view is acquired, itis usually assumed that there is no offset of the leads on the lateralview. However, in some cases, the visual estimate of lead proximity froman AP fluoroscopic image may incorrectly indicate that the leads are inclose proximity, when in fact, the leads may be actually be quiteseparated from each other; something that may only be detected from alateral fluoroscopic image of the leads. If such lead placement is notdetected in a timely manner before the system is fully implanted, it mayresult in inefficient therapy and possibly require a second surgery forlead revision.

In addition, when programming a transverse tripolar system, knowingwhich electrode is in the middle of the medio-lateral electrodearrangement is absolutely critical to selecting the cathode thatprovides the stimulation, as well as selecting the anodes that providethe guarding function. Once the leads have been implanted, identifyingthe middle stimulation lead can be challenging.

Oftentimes, multiple leads may extend from the spinal region of thepatient. For example, multiple percutaneous leads may be implantedwithin the patient adjacent the spinal cord. Because the programming ofthe IPG will depend upon the physical locations of the electrodesrelative to the patient's spinal cord (especially in the case of atripolar system as just described), the proximal ends of the leads maybe labeled before passing them through the tunneling straw, so that thesurgeon can keep track of which set of electrodes is connected to whichconnector port on the implanted IPG (which may include three ports for amedio-lateral electrode arrangement).

One technique used by surgeons to identify the leads is to tie suturesaround the proximal ends of the leads prior to introducing them throughthe tunneling straw; for example, one suture around a first lead, twosutures around a second lead, three sutures around a third lead, etc.Once the proximal ends of the leads exit the tunneling straw, thesurgeon can then identify each lead (and thus the correspondingelectrodes) by the number of sutures tied to the respective lead,thereby allowing the lead to be connected to the correct port on theIPG.

While this technique can be successfully employed to identify leads, itconsiderably extends the length of the surgery time, which isundesirable. In some cases, the identification features, such asdifferent colors or markings, can be incorporated into the proximal endsof the leads, such that the leads can be identified as they exit thetunneling straw. Even with the use of visual identifiers, however, theproximal ends of the leads can still be inserted into the incorrectconnector ports, or the distal ends of the leads may have been mixed upduring lead insertion, and therefore, the visual identifiers will notcorrespond to their intended electrodes. If the leads are inserted intothe incorrect connector ports, intra-operative testing of the leadplacement may be compromised. Additional surgical time may be wasted toidentify and correct the connection problem. If the errors remainunidentified, the patient may leave the operating room with the leadsincorrectly connected. During post-operative fitting, additional timemay then be lost identifying and compensating for leads that are not inthe proper connector ports. This ultimately can result in sub-optimaltherapy.

Another technique that can be used to identify the leads is toindividually activate stimulation for each lead and request the patientto provide paresthesia feedback (e.g., feeling from left, right, or bothsides of the body) in order to determine the medio-lateral order of theleads. This could be time-consuming and may become confusing if themiddle lead is placed laterally to the spinal cord physiologicalmidline. Also, this conventional method may not be able to reveal therelative proximity of the two lateral leads absent a fluoroscopicprocedure.

Additionally, in the case where multiple percutaneous leads are used toconstruct the medio-lateral electrode arrangement, knowing the relativeproximity of the lateral leads to the middle lead is also helpful insculpting the current/voltage applied to each guarding anode.Furthermore, the leads may not be oriented perfectly parallel, butrather tilted at an angle. In such cases, knowing the proximity (and inparticular, the separation between two adjacent cross-lead electrodes)and relative orientation of the leads to each other may be critical tosculpting the stimulation current/voltage applied to each activeelectrode.

There, thus, remains a need for a quick, effective, and low-cost methodfor determining the relative proximity and orientation between two ormore neurostimulation leads and/or identifying the middle lead of atri-lead system.

SUMMARY OF THE INVENTION

In accordance with a first aspect of the present inventions, a method ofoperating two leads disposed adjacent tissue of a patient is provided.The method comprises activating one of a pair of electrodes respectivelycarried by the two leads to generate an electrical field within thetissue (e.g. spinal cord tissue). The method further comprises measuringan electrical parameter (e.g., a field potential or an impedance) inresponse to the generated electrical field at the other of the pair ofelectrodes, and measuring a reference electrical parameter (e.g., afield potential or an impedance) in response to the generated electricalfield at a reference electrode carried by the same one of the two leadsthat carries the one electrode. For the purposes of this specification,the electrical field measured at the other electrode and referenceelectrode may be generated by the activated electrode at the same timeor may be generated at different times. A reference distance between theone electrode and the reference electrode is known prior to thegeneration of the electrical field. One optional method furthercomprises determining a longitudinal stagger between the two leads, andselecting the pair of electrodes having the least amount of longitudinalstagger based on the determined longitudinal stagger.

The method further comprises computing a ratio between the measuredelectrical parameter and the measured reference electrical parameter,and computing a distance between the pair of electrodes as a function ofthe computed ratio and the reference distance. In one method, the ratiomay be computed by dividing the measured electrical parameter by themeasured reference electrical parameter, in which case, the function maybe a division (e.g., if the electrical parameter is a field potential)or multiplication (e.g., if the electrical parameter is an impedance) ofthe reference distance by the computed ratio. In another method, theratio may be computed by dividing the measured reference electricalparameter by the measured electrical parameter, in which case, thefunction may be a multiplication (e.g., if the electrical parameter is afield potential) or division (e.g., if the electrical parameter is animpedance) of the reference distance by the computed ratio.

One method further comprises determining the relative positioning (e.g.,distance and/or angle) between the two leads at least partially based onthe computed distance. In this case, the method may further compriseactivating one of another pair of electrodes respectively carried by thetwo leads to generate another electrical field within the tissue,repeating the electrical parameter measuring for the remaining one ofthe other pair of electrodes, repeating the reference electricalparameter measuring for another reference electrode, and repeating theratio computing and distance computing steps to determine anotherdistance between the other pair of electrodes.

The method may further comprise plotting the distances, and fitting alead model to the plotted distances, wherein the relative positioningbetween the two leads is determined based on the fitted lead model. Inanother method, three leads are operated, with one being a middle leadand the remaining pair of leads flanking the middle lead. In this case,the method may further comprise identifying the middle lead based on thecomputed distance. The method may further comprise displaying therelative positioning of the two leads based on the computed distanceand/or programming a neurostimulator with a plurality of stimulationparameters based on the computed distance.

In accordance with a second aspect of the present inventions, a medicalsystem is provided. The medical system comprises a first and secondleads configured for being placed adjacent tissue of a patient. Thefirst lead carries a first electrode and a reference electrode, and thesecond lead carries a second electrode. The medical system furthercomprises a controller configured for activating the first electrode togenerate an electrical field within the tissue. The medical systemfurther comprises monitoring circuitry configured for measuring anelectrical parameter (e.g., a field potential or impedance) in responseto the generated electrical field at the second electrode, and measuringa reference electrical parameter (e.g., a field potential or impedance)in response to the generated electrical field at the referenceelectrode. A reference distance between the first electrode and thereference electrode is known prior to generation of the electricalfield. In an optional embodiment, processor(s) is configured fordetermining a longitudinal stagger between the two leads, and selectingthe first and second electrodes having the least amount of longitudinalstagger based on the determined longitudinal stagger.

The medical system further comprises at least one processor configuredfor computing a ratio between the measured electrical parameter and themeasured reference electrical parameter, and computing a distancebetween the first and second electrodes as a function of the computedratio and the reference distance. As one example, the processor(s) maybe configured for computing ratio by dividing the measured electricalparameter by the measured reference electrical parameter, in which case,the function may be a division (e.g., if the electrical parameter is afield potential) or multiplication (e.g., if the electrical parameter isan impedance) of the reference distance by the computed ratio. Asanother example, the processor(s) may be configured for computing ratioby dividing the measured reference electrical parameter by the measuredelectrical parameter, in which case, the function may be amultiplication (e.g., if the electrical parameter is a field potential)or division (e.g., if the electrical parameter is an impedance) of thereference distance by the computed ratio. In one embodiment, theprocessor(s) is configured for determining the relative positioning(e.g., distance and/or angle) between the two leads at least partiallybased on the computed distance.

In another embodiment, the first lead carries a third electrode andanother reference electrode, and the second lead carries a fourthelectrode. In this case, the controller may be configured for activatingthe third electrode to generate another electrical field within thetissue, the monitoring circuitry may be configured for repeating theelectrical parameter measuring and the reference electrical parametermeasuring with respect to the fourth electrode and the other referenceelectrode, and the processor(s) may be configured for performing theratio computing and distance computing to determine another distancebetween the third and fourth electrodes. The processor(s) may also beconfigured for plotting the first and second distances, fitting astraight line or a curve to the first and second plotted distances, anddetermining the relative positioning between the two leads based on thefitted straight line or curve.

In another embodiment, the medical system further comprises a third leadconfigured for being placed adjacent tissue of a patient, with thefirst, second, and third leads being configured to be arranged as amiddle lead and two leads flanking the middle leads. In this case, theprocessor(s) is configured for identifying the middle lead based on thecomputed distance.

In an optional embodiment, the medical system further comprises amonitor configured for displaying the relative positioning of the twoleads based on the computed distance. In another optional embodiment,the medical system further comprises a neurostimulator and an externaldevice. In this case, the controller may be contained within theimplantable device, and one or more of the processors may be containedwithin the external device.

Other and further aspects and features of the invention will be evidentfrom reading the following detailed description of the preferredembodiments, which are intended to illustrate, not limit, the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of preferred embodimentsof the present invention, in which similar elements are referred to bycommon reference numerals. In order to better appreciate how theabove-recited and other advantages and objects of the present inventionsare obtained, a more particular description of the present inventionsbriefly described above will be rendered by reference to specificembodiments thereof, which are illustrated in the accompanying drawings.Understanding that these drawings depict only typical embodiments of theinvention and are not therefore to be considered limiting of its scope,the invention will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 is plan view of one embodiment of a spinal cord stimulation (SCS)system arranged in accordance with the present inventions;

FIG. 2 is a plan view of an implantable pulse generator (IPG) andanother embodiment of a percutaneous stimulation lead used in the SCSsystem of FIG. 1;

FIG. 3 is a plan view of the SCS system of FIG. 1 in use with a patient;

FIG. 4 is a block diagram of the internal components of the IPG of FIG.1;

FIG. 5 is a plan view of a remote control that can be used in the SCSsystem of FIG. 1;

FIG. 6 is a block diagram of the internal componentry of the remotecontrol of FIG. 5;

FIG. 7 is a block diagram of the components of a clinician's programmerthat can be used in the SCS system of FIG. 1;

FIG. 8 is a plan view of two neurostimulation leads used in the SCSsystem of FIG. 1;

FIG. 9 is a plot of measured cross-lead versus intra-lead fieldpotential measurements as a function of separation distance betweenelectrodes carried by the two neurostimulation leads of FIG. 8;

FIG. 10 is a flow diagram showing the process used by the CP of the SCSsystem of FIG. 1 to determine the relative positioning of theneurostimulation leads shown of FIG. 8;

FIG. 11 is a look-up table of cross-lead/intra-lead field potentialratios and corresponding electrode separation distance values used bythe CP to determine the relative positioning of the neurostimulationleads shown of FIG. 8; and

FIG. 12 is a plot of distance values calculated by the CP and a model ofa lead fitted to the distance values.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The description that follows relates to a spinal cord stimulation (SCS)system. However, it is to be understood that while the invention lendsitself well to applications in SCS, the invention, in its broadestaspects, may not be so limited. Rather, the invention may be used withany type of implantable electrical circuitry used to stimulate tissue.For example, the present invention may be used as part of a pacemaker, adefibrillator, a cochlear stimulator, a retinal stimulator, a stimulatorconfigured to produce coordinated limb movement, a cortical stimulator,a deep brain stimulator, peripheral nerve stimulator, microstimulator,or in any other neural stimulator configured to treat urinaryincontinence, sleep apnea, shoulder sublaxation, headache, etc.

Turning first to FIG. 1, an exemplary SCS system 10 generally comprisesa plurality of percutaneous leads 12 (in this case, three), animplantable pulse generator (IPG) 14, an external remote control (RC)16, a Clinician's Programmer (CP) 18, an External Trial Stimulator (ETS)20, and an external charger 22.

The IPG 14 is physically connected via three lead extensions 24 to thestimulation lead 12, which carry a plurality of electrodes 26 arrangedin an array. As will also be described in further detail below, the IPG14 includes pulse generation circuitry that delivers electricalstimulation energy in the form of a pulsed electrical waveform (i.e., atemporal series of electrical pulses) to the electrode array 26 inaccordance with a set of stimulation parameters. The IPG 14 andstimulation leads 12 can be provided as an implantable neurostimulationkit, along with, e.g., a hollow needle, a stylet, a tunneling tool, anda tunneling straw. Further details discussing implantable kits aredisclosed in U.S. Application Ser. No. 61/030,506, entitled “TemporaryNeurostimulation Lead Identification Device,” which is expresslyincorporated herein by reference.

The ETS 20 may also be physically connected via percutaneous leadextensions 28 or external cable 30 to the stimulation lead 12. The ETS20, which has similar pulse generation circuitry as the IPG 14, alsodelivers electrical stimulation energy in the form of a pulse electricalwaveform to the electrode array 26 in accordance with a set ofstimulation parameters. The major difference between the ETS 20 and theIPG 14 is that the ETS 20 is a non-implantable device that is used on atrial basis after the stimulation lead 12 has been implanted and priorto implantation of the IPG 14, to test the responsiveness of thestimulation that is to be provided. Further details of an exemplary ETSare described in U.S. Pat. No. 6,895,280, which is expresslyincorporated herein by reference.

The RC 16 may be used to telemetrically control the ETS 20 via abi-directional RF communications link 32. Once the IPG 14 andstimulation lead 12 is implanted, the RC 16 may be used totelemetrically control the IPG 14 via a bi-directional RF communicationslink 34. Such control allows the IPG 14 to be turned on or off and to beprogrammed with different stimulation programs after implantation. Oncethe IPG 14 has been programmed, and its power source has been charged orotherwise replenished, the IPG 14 may function as programmed without theRC 16 being present.

The CP 18 provides clinician detailed stimulation parameters forprogramming the IPG 14 and ETS 20 in the operating room and in follow-upsessions. The CP 18 may perform this function by indirectlycommunicating with the IPG 14 or ETS 20, through the RC 16, via an IRcommunications link 36. Alternatively, the CP 18 may directlycommunicate with the IPG 14 or ETS 20 via an RF communications link (notshown).

The external charger 22 is a portable device used to transcutaneouslycharge the IPG 14 via an inductive link 38. For purposes of brevity, thedetails of the external charger 22 will not be described herein. Detailsof exemplary embodiments of external chargers are disclosed in U.S. Pat.No. 6,895,280, which has been previously incorporated herein byreference. Once the IPG 14 has been programmed, and its power source hasbeen charged by the external charger 22 or otherwise replenished, theIPG 14 may function as programmed without the RC 16 or CP 18 beingpresent.

Referring now to FIG. 2, the external features of the stimulation leads12 and the IPG 14 will be briefly described. Each of the stimulationleads 12 has eight electrodes 26 (respectively labeled E1-E8, E9-E16,and E17-E24). The actual number and shape of leads and electrodes will,of course, vary according to the intended application. Further detailsdescribing the construction and method of manufacturing percutaneousstimulation leads are disclosed in U.S. patent application Ser. No.11/689,918, entitled “Lead Assembly and Method of Making Same,” and U.S.patent application Ser. No. 11/565,547, entitled “CylindricalMulti-Contact Electrode Lead for Neural Stimulation and Method of MakingSame,” the disclosures of which are expressly incorporated herein byreference.

The IPG 14 comprises an outer case 40 for housing the electronic andother components (described in further detail below). The outer case 40is composed of an electrically conductive, biocompatible material, suchas titanium, and forms a hermetically sealed compartment wherein theinternal electronics are protected from the body tissue and fluids. Insome cases, the outer case 40 may serve as an electrode. The IPG 14further comprises a connector 42 to which the proximal ends of thestimulation leads 12 mate in a manner that electrically couples theelectrodes 26 to the internal electronics (described in further detailbelow) within the outer case 40. To this end, the connector 42 includesthree ports 44 (only one shown in phantom) for receiving the proximalends of the three percutaneous leads 12. In the case where the leadextensions 24 are used, the ports 44 may instead receive the proximalends of such lead extensions 24.

As will be described in further detail below, the IPG 14 includes pulsegeneration circuitry that provides electrical stimulation energy to theelectrodes 26 in accordance with a set of parameters. Such parametersmay comprise electrode combinations, which define the electrodes thatare activated as anodes (positive), cathodes (negative), and turned off(zero), and electrical pulse parameters, which define the pulseamplitude (measured in milliamps or volts depending on whether the IPG14 supplies constant current or constant voltage to the electrodes),pulse duration (measured in microseconds), pulse rate (measured inpulses per second), and pulse shape.

With respect to the pulse patterns provided during operation of the SCSsystem 10, electrodes that are selected to transmit or receiveelectrical energy are referred to herein as “activated,” whileelectrodes that are not selected to transmit or receive electricalenergy are referred to herein as “non-activated.” Electrical energydelivery will occur between two (or more) electrodes, one of which maybe the IPG case 40, so that the electrical current has a path from theenergy source contained within the IPG case 40 to the tissue and a sinkpath from the tissue to the energy source contained within the case.Electrical energy may be transmitted to the tissue in a monopolar ormultipolar (e.g., bipolar, tripolar, etc.) fashion.

Monopolar delivery occurs when a selected one or more of the leadelectrodes 26 is activated along with the case 40 of the IPG 14, so thatelectrical energy is transmitted between the selected electrode 26 andcase 40. Monopolar delivery may also occur when one or more of the leadelectrodes 26 are activated along with a large group of lead electrodeslocated remotely from the one or more lead electrodes 26 so as to createa monopolar effect; that is, electrical energy is conveyed from the oneor more lead electrodes 26 in a relatively isotropic manner. Bipolardelivery occurs when two of the lead electrodes 26 are activated asanode and cathode, so that electrical energy is transmitted between theselected electrodes 26. Tripolar delivery occurs when three of the leadelectrodes 26 are activated, two as anodes and the remaining one as acathode, or two as cathodes and the remaining one as an anode.

Referring to FIG. 3, the stimulation leads 12 are implanted within thespinal column 46 of a patient 48. The preferred placement of thestimulation leads 12 is adjacent, i.e., resting near, or upon the dura,adjacent to the spinal cord area to be stimulated. Due to the lack ofspace near the location where the stimulation leads 12 exit the spinalcolumn 46, the IPG 14 is generally implanted in a surgically-made pocketeither in the abdomen or above the buttocks. The IPG 14 may, of course,also be implanted in other locations of the patient's body. The leadextensions 24 facilitate locating the IPG 14 away from the exit point ofthe stimulation leads 12. As there shown, the CP 18 communicates withthe IPG 14 via the RC 16. While the stimulation leads 12 are illustratedas being implanted near the spinal cord area of a patient, thestimulation leads 12 may be implanted anywhere in the patient's body,including a peripheral region, such as a limb, or the brain. It can beappreciated from the foregoing that the three percutaneous leads 12allow three columns of electrodes 26 (in this case, E1-E8, E9-E16, andE17-E24) can be located along the spinal cord tissue. In this manner,three adjacent electrodes 26 from the respective electrode columns canbe transversely placed across spinal cord tissue to form a medio-lateralelectrode arrangement, with one of the electrodes 26 being used as amiddle electrode, and the remaining two electrodes 26 being used asflanking electrodes. After implantation, the IPG 14 is used to providethe therapeutic stimulation under control of the patient.

Turning next to FIG. 4, the main internal components of the IPG 14 willnow be described. The IPG 14 includes stimulation output circuitry 60configured for generating electrical stimulation energy in accordancewith a defined pulsed waveform having a specified pulse amplitude, pulserate, pulse width, pulse shape, and burst rate under control of controllogic 62 over data bus 64. Control of the pulse rate and pulse width ofthe electrical waveform is facilitated by timer logic circuitry 66,which may have a suitable resolution, e.g., 10 μs. The stimulationenergy generated by the stimulation output circuitry 60 is output viacapacitors C1-C16 to electrical terminals 68 corresponding to theelectrodes 26.

The analog output circuitry 60 may either comprise independentlycontrolled current sources for providing stimulation pulses of aspecified and known amperage to or from the electrical terminals 68, orindependently controlled voltage sources for providing stimulationpulses of a specified and known voltage at the electrical terminals 68or to multiplexed current or voltage sources that are then connected tothe electrical terminals 68. The operation of this analog outputcircuitry, including alternative embodiments of suitable outputcircuitry for performing the same function of generating stimulationpulses of a prescribed amplitude and width, is described more fully inU.S. Pat. Nos. 6,516,227 and 6,993,384, which are expressly incorporatedherein by reference.

The IPG 14 further comprises monitoring circuitry 70 for monitoring thestatus of various nodes or other points 72 throughout the IPG 14, e.g.,power supply voltages, temperature, battery voltage, and the like.Notably, the electrodes 26 fit snugly within the epidural space of thespinal column, and because the tissue is conductive, electricalmeasurements can be taken from the electrodes 26. Significantly, themonitoring circuitry 70 is configured for taking such electricalmeasurements, so that, as will be described in further detail below, theCP 18 can automatically determine the relative positioning between theleads 12, as well as to identify the middle lead 12 in the case where atripolar lead arrangement is utilized. In the illustrated embodiment,the electrical measurements taken by the monitoring circuitry 70 for thepurpose of identifying the connected lead bodies, are field potentialsor other electrical parameters (e.g., current and/or impedance) that maybe used to derive the field potential. The monitoring circuitry 70 mayalso measure impedance at each electrode 26 in order to determine thecoupling efficiency between the respective electrode 26 and the tissueand/or to facilitate fault detection with respect to the connectionbetween the electrodes 26 and the analog output circuitry 60 of the IPG14.

Electrical data can be measured using any one of a variety means. Forexample, the electrical data measurements can be made on a sampled basisduring a portion of the time while the electrical stimulus pulse isbeing applied to the tissue, or immediately subsequent to stimulation,as described in U.S. patent application Ser. No. 10/364,436, which haspreviously been incorporated herein by reference. Alternatively, theelectrical data measurements can be made independently of the electricalstimulation pulses, such as described in U.S. Pat. Nos. 6,516,227 and6,993,384, which are expressly incorporated herein by reference.

The IPG 14 further comprises processing circuitry in the form of amicrocontroller 74 that controls the control logic 62 over data bus 76,and obtains status data from the monitoring circuitry 70 via data bus78. The microcontroller 74 additionally controls the timer logic 66. TheIPG 14 further comprises memory 80 and an oscillator and clock circuit82 coupled to the microcontroller 74. The microcontroller 74, incombination with the memory 80 and oscillator and clock circuit 82, thuscomprise a microprocessor system that carries out a program function inaccordance with a suitable program stored in the memory 80.Alternatively, for some applications, the function provided by themicroprocessor system may be carried out by a suitable state machine.

Thus, the microcontroller 74 generates the necessary control and statussignals, which allow the microcontroller 74 to control the operation ofthe IPG 14 in accordance with a selected operating program andparameters. In controlling the operation of the IPG 14, themicrocontroller 74 is able to individually generate electrical pulses atthe electrodes 26 using the analog output circuitry 60, in combinationwith the control logic 62 and timer logic 66, thereby allowing eachelectrode 26 to be paired or grouped with other electrodes 26, includingthe monopolar case electrode, and to control the polarity, amplitude,rate, and pulse width through which the current stimulus pulses areprovided.

The IPG 14 further comprises an alternating current (AC) receiving coil84 for receiving programming data (e.g., the operating program and/orstimulation parameters) from the RC 16 in an appropriate modulatedcarrier signal, and charging and forward telemetry circuitry 86 fordemodulating the carrier signal it receives through the AC receivingcoil 84 to recover the programming data, which programming data is thenstored within the memory 80, or within other memory elements (not shown)distributed throughout the IPG 14.

The IPG 14 further comprises back telemetry circuitry 88 and analternating current (AC) transmission coil 90 for sending informationaldata (including the field potential and impedance data) sensed throughthe monitoring circuitry 70 to the RC 16. The back telemetry features ofthe IPG 14 also allow its status to be checked. For example, any changesmade to the stimulation parameters are confirmed through back telemetry,thereby assuring that such changes have been correctly received andimplemented within the IPG 14. Moreover, upon interrogation by the RC16, all programmable settings stored within the IPG 14 may be uploadedto the RC 16.

The IPG 14 further comprises a rechargeable power source 92 and powercircuits 94 for providing the operating power to the IPG 14. Therechargeable power source 92 may, e.g., comprise a lithium-ion orlithium-ion polymer battery. The rechargeable battery 92 provides anunregulated voltage to the power circuits 94. The power circuits 94, inturn, generate the various voltages 96, some of which are regulated andsome of which are not, as needed by the various circuits located withinthe IPG 14. The rechargeable power source 92 is recharged usingrectified AC power (or DC power converted from AC power through othermeans, e.g., efficient AC-to-DC converter circuits) received by the ACreceiving coil 84. To recharge the power source 92, an external charger(not shown), which generates the AC magnetic field, is placed against,or otherwise adjacent, to the patient's skin over the implanted IPG 14.The AC magnetic field emitted by the external charger induces ACcurrents in the AC receiving coil 84. The charging and forward telemetrycircuitry 86 rectifies the AC current to produce DC current, which isused to charge the power source 92. While the AC receiving coil 84 isdescribed as being used for both wirelessly receiving communications(e.g., programming and control data) and charging energy from theexternal device, it should be appreciated that the AC receiving coil 84can be arranged as a dedicated charging coil, while another coil, suchas coil 90, can be used for bi-directional telemetry.

It should be noted that the diagram of FIG. 4 is functional only, and isnot intended to be limiting. Those of skill in the art, given thedescriptions presented herein, should be able to readily fashionnumerous types of IPG circuits, or equivalent circuits, that carry outthe functions indicated and described. It should be noted that ratherthan an IPG for the neurostimulator, the SCS system 10 may alternativelyutilize an implantable receiver-stimulator (not shown) connected to thestimulation leads 12. In this case, the power source, e.g., a battery,for powering the implanted receiver, as well as control circuitry tocommand the receiver-stimulator, will be contained in an externalcontroller inductively coupled to the receiver-stimulator via anelectromagnetic link. Data/power signals are transcutaneously coupledfrom a cable-connected transmission coil placed over the implantedreceiver-stimulator. The implanted receiver-stimulator receives thesignal and generates the stimulation in accordance with the controlsignals.

Referring now to FIG. 5, one exemplary embodiment of an RC 16 will nowbe described. As previously discussed, the RC 16 is capable ofcommunicating with the IPG 14, CP 18, or ETS 20. The RC 16 comprises acasing 100, which houses internal componentry (including a printedcircuit board (PCB)), and a lighted display screen 102 and button pad104 carried by the exterior of the casing 100. In the illustratedembodiment, the display screen 102 is a lighted flat panel displayscreen, and the button pad 104 comprises a membrane switch with metaldomes positioned over a flex circuit, and a keypad connector connecteddirectly to a PCB. In an optional embodiment, the display screen 102 hastouchscreen capabilities. The button pad 104 includes a multitude ofbuttons 106, 108, 110, and 112, which allow the IPG 14 to be turned ONand OFF, provide for the adjustment or setting of stimulation parameterswithin the IPG 14, and provide for selection between screens.

In the illustrated embodiment, the button 106 serves as an ON/OFF buttonthat can be actuated to turn the IPG 14 ON and OFF. The button 108serves as a select button that allows the RC 106 to switch betweenscreen displays and/or parameters. The buttons 110 and 112 serve asup/down buttons that can be actuated to increase or decrease any ofstimulation parameters of the pulse generated by the IPG 14, includingpulse amplitude, pulse width, and pulse rate.

Referring to FIG. 6, the internal components of an exemplary RC 16 willnow be described. The RC 16 generally includes a processor 114 (e.g., amicrocontroller), memory 116 that stores an operating program forexecution by the processor 114, and telemetry circuitry 118 fortransmitting control data (including stimulation parameters and requeststo provide status information) to the IPG 14 (or ETS 20) and receivingstatus information (including the measured electrical data) from the IPG14 (or ETS 20) via link 34 (or link 32) (shown in FIG. 1), as well asreceiving the control data from the CP 18 and transmitting the statusdata to the CP 18 via link 36 (shown in FIG. 1). The RC 16 furtherincludes input/output circuitry 120 for receiving stimulation controlsignals from the button pad 104 and transmitting status information tothe display screen 102 (shown in FIG. 5). Further details of thefunctionality and internal componentry of the RC 16 are disclosed inU.S. Pat. No. 6,895,280, which has previously been incorporated hereinby reference.

As briefly discussed above, the CP 18 greatly simplifies the programmingof multiple electrode combinations, allowing the physician or clinicianto readily determine the desired stimulation parameters to be programmedinto the IPG 14, as well as the RC 16. Thus, modification of thestimulation parameters in the programmable memory of the IPG 14 afterimplantation is performed by a clinician using the CP 18, which candirectly communicate with the IPG 14 or indirectly communicate with theIPG 14 via the RC 16. That is, the CP 18 can be used by the physician orclinician to modify operating parameters of the electrode array 26 nearthe spinal cord.

As shown in FIG. 3, the overall appearance of the CP 18 is that of alaptop personal computer (PC), and in fact, may be implemented using aPC that has been appropriately configured to include adirectional-programming device and programmed to perform the functionsdescribed herein. Thus, the programming methodologies can be performedby executing software instructions contained within the CP 18.Alternatively, such programming methodologies can be performed usingfirmware or hardware. In any event, the CP 18 may actively control thecharacteristics of the electrical stimulation generated by the IPG 14(or ETS 20) to allow the optimum stimulation parameters to be determinedbased on patient feedback and for subsequently programming the IPG 14(or ETS 20) with the optimum stimulation parameters.

To allow the clinician to perform these functions, the CP 18 includes amouse 121, a keyboard 122, and a programming display screen 124 housedin a case 126. It is to be understood that in addition to, or in lieuof, the mouse 121, other directional programming devices may be used,such as a joystick, or directional keys included as part of the keysassociated with the keyboard 122. As shown in FIG. 7, the CP 18generally includes a processor 128 (e.g., a central processor unit(CPU)) and memory 130 that stores a stimulation programming package 132,which can be executed by the processor 128 to allow a clinician toprogram the IPG 14 (or ETS 20) and RC 16. The CP 18 further includestelemetry circuitry 134 for downloading stimulation parameters to the RC16 and uploading stimulation parameters already stored in the memory 116of the RC 16 via link 36 (shown in FIG. 1). The telemetry circuitry 134is also configured for transmitting the control data (includingstimulation parameters and requests to provide status information) tothe IPG 14 (or ETS 20) and receiving status information (including themeasured electrical data) from the IPG 14 (or ETS 20) indirectly via theRC 16.

The CP 18 is configured for automatically determining the relativepositioning (e.g., the separation and/or tilt angle) of the percutaneousleads 12 by taking one or more cross-lead electrical field measurementsand comparing these measurements to reference intra-lead electricalfield measurements to determine the separation distance between pairs ofcross-lead electrodes. In the embodiment described below, fieldpotential measurements are taken, although other types of measurements,such as impedance measurements, can alternatively be taken.

With reference to FIG. 8, the CP 18 can determine the separationdistances between any pair of cross-lead electrodes (e.g., electrodes E4and E11) by activating one electrode (e.g., electrode E4) of therespective electrode pair to generate an electrical field within thetissue, measuring an electrical parameter (in this case, the fieldpotential) at the other electrode (e.g., electrode E11) of the electrodepair, and measuring an electrical parameter (in this case, the fieldpotential) at an electrode located on the same lead (e.g., electrode E5)in which the activated electrode is located. Notably, any electrode onthe same lead as the activated electrode can be used as long as thedistance between the two electrodes is known. The electrical field canbe monopolar (i.e., generated between the activated electrode and thecase of the IPG) or bipolar (i.e., generated between the activatedelectrode and a return electrode on a lead).

Notably, for an electrical field resulting from a constant point currentsource in a medium of conductivity a, the measured field potential isinversely proportionate to the product of the distance and theconductivity between the “driving” (or “active”) electrode and themeasurement electrode, and can be expressed as follows:FP_e_(m)(E_(n))∞1/rσ, where FP_e_(m)(E_(n)) is the magnitude of themeasured field potential generated at an activated electrode e_(m) andmeasured at an electrode E_(n), r is the distance between the activatedelectrode e_(m) and the measurement electrode E_(n), σ is theconductivity between the active electrode e_(m) and the measurementelectrode E_(n), and m and n are respectively the electrode numbers.

Since the separation distance between two intra-lead electrodes (e.g.,electrodes E4 and E5) is fixed and known, it may serve as a referencefor the estimate of separation between two cross-lead electrodes (e.g.,electrodes E4 and E11). For the same activated electrode (e.g.,electrode E4), the ratio of the field potential FP measured from across-lead electrode (e.g., electrode E11), and the field potential FPmeasured from an intra-lead electrode (e.g., electrode E5) can beexpressed as follows: [2]R=FP_e₄(E₁₁)/FP_e₄(E₅)=Lσ_(L)/dσ_(d) where L isthe separation distance between the activated electrode and theintra-lead measurement electrode, d is the separation distance betweenthe activated electrode and cross-lead measurement electrode, σ_(L) isthe intra-lead conductivity (i.e., the conductivity between theactivated electrode and the intra-lead measurement electrode), and σ_(d)is the cross-lead conductivity (i.e., the conductivity between theactivated electrode and the cross-lead measurement electrode).

If the conductivities σ_(L) and σ_(d) or the ratio of conductivitiesσ_(L) and σ_(d) (i.e., σ_(L)/σ_(d)) are known, the ratio R is then afunction of the separation distance d between the activated electrodeand the cross-lead measurement electrode (denoted R(d)). If therelationship between the ratio R and separation distance d isdetermined, monotonic, and known, the separation distance d can bereadily retrieved for a given ratio R. For a homogeneous medium (i.e.,σ_(L)≈σ_(d)), this relationship becomes an ideal case. For aheterogeneous medium (i.e., σ_(L)≠σ_(d)), the ratio of conductivitiesσ_(L) and σ_(d) (i.e., σ_(L)/σ_(d)) must be taken into account. Forexample, the ratio of the conductivities σ_(L) and σ_(d) can bedetermined by taking an ex-vivo conductivity measurement longitudinallyalong sample spinal cord tissue to provide an estimate for theintra-lead conductivity σ_(L), and taking an ex-vivo conductivitymeasurement transversely along the spinal cord tissue to provide anestimate for the cross-lead conductivity σ_(d).

An accurate and representative reference data set for the fieldpotential ratio R as a function of the separation distance d between theactivated electrode e_(m) and the measuring electrode E_(n), (i.e.,R(d)) can be obtained through conventional techniques, such ascomputational modeling, experiments on phantom models, or experiments onanimal modes. For example with reference to FIG. 9, an example of ameasured field potential ratio R (i.e., cross-lead vs. intra-lead) as afunction of a cross-lead electrode separation distance d is shown. Thisdata was obtained from a Finite Element Model (FEM) of a tripolar leadconfiguration for SCS. Such data may also be obtained computationally,empirically, or experimentally. As there shown, the ratio R is amonotonic function of the cross-lead electrode separation d, and thus,the inverse solution of the cross-lead electrode separation distance dis unique. Thus, for each value of the field potential ratio R, acorresponding cross-lead electrode separation distance d can bedetermined by either a look-up table or an explicit inverse function.

As briefly discussed above, the relative positioning between twopercutaneous leads 12 can be determined based on the separationdistances between pairs of cross-lead electrodes. In particular, andwith reference to FIG. 10, reference data in the form of a look-up tablethat includes reference field potential ratios R_(REF) and associatedcross-lead electrode separation distances d can be generated at step200. An exemplary look-up table generated from the field potentialratios R versus lead separation data d of FIG. 9 is shown in FIG. 11.The reference field potential ratios R_(REF) can be stored in the memory130 of the processor 128 (see FIG. 7). Alternatively, instead of usingreference field potential ratios R_(REF), a reciprocal of the referencefield potential ratios R_(REF) and associated cross-lead electrodeseparation distances d can be stored in a look-up table. In either case,a ratio between the measured cross-lead field potential and the measuredintra-lead field potential (either the measured cross-lead fieldpotential divided by the measured intra-lead field potential or themeasured intra-lead field potential divided by the measured cross-leadfield potential) is computed.

Next, the cross-lead electrodes [e_(m), E_(n)] and intra-lead electrodes[e_(m), E_(m±i)] that are to be used to generate and measure theelectrical fields (i.e., one cross-lead electrode pair and oneintra-lead electrode pair) are selected at step 202. The variable i canbe 1, 2, 3, 4, etc, or any number, as long as the distance between theintra-lead electrodes is known. Preferably, however, the variable i is 1to minimize errors in the calculation. Thus, an electrode carried by oneof the leads is selected as the activated electrode, an electrodecarried by another one of the leads is selected as the cross-leadmeasurement electrode, and an electrode carried by the same lead thatcarries the activated electrode is selected as the intra-leadmeasurement electrode. Preferably, the intra-lead measurement electrodeis immediately adjacent the activated electrode (i.e., directly above ordirectly below the activated electrode), and the cross-lead measurementelectrode is immediately adjacent (or across) from the activatedelectrode. For example, as discussed above with respect to FIG. 8,electrodes E4 and E11 can be selected as the cross-lead electrode pair,and electrodes E4 and E5 or electrodes E4 and E3 can be selected as theintra-lead electrode pair. In some cases, the leads may belongitudinally staggered, and therefore, the cross-lead electrodes maynot necessarily be those that would be directly across from each otherin the case where the leads are longitudinally aligned. For example, ifthe leads illustrated in FIG. 8 were not longitudinally staggered,electrodes E4 and E12 would be selected as the cross-lead electrodes.However, due to a longitudinal stagger of one electrode, electrodes E4and E11 are selected.

In the case where the leads are longitudinally staggered, the pair ofelectrodes that are respectively selected as the activated electrode andthe cross-lead measurement electrode preferably have the least amount oflongitudinal stagger in order to minimize any error in determining theseparation distance d between the cross-lead electrodes. To make thisdetermination, it will be necessary to determine the longitudinalstagger of the respective leads. This longitudinal lead stagger may bedetermined using conventional means, such as fluoroscopy, or may beperformed electronically using techniques described in U.S. patentapplication Ser. No. 11/557,484, entitled “System and Method forComputationally Determining Migration of Neurostimulation Leads,” orU.S. Pat. No. 6,993,384, entitled “Apparatus and Method for Determiningthe Relative Position and Orientation of Neurostimulation Leads,” whichare expressly incorporated herein by reference. Once the longitudinallead stagger is determined, the cross-lead electrode pair can beselected either manually (e.g., user input into the CP 18) orautomatically by the CP 18.

After the cross-lead electrode pair and the intra-lead electrode pairare selected, the cross-lead electrode pair is operated to generate andmeasure the electrical field to obtain a cross-lead field potentialmeasurement FP_(em)(E_(n)), and the intra-lead electrode pair isoperated to generate and measure the electrical field to obtain anintra-lead field potential measurement FP_(em)(E_(m±1)) at step 204. TheCP 18 can perform this step by transmitting appropriate control data tothe IPG 14 to initiate generation of the electrical field via the analogoutput circuitry 60 and measuring of the field potentials via themonitoring circuitry 70 (see FIG. 4). This field potential data can thenbe telemetered from the back telemetry circuitry 88 of the IPG 14 to thetelemetry circuitry 134 of the CP 18 (see FIG. 7). Such control data andmeasured field potential data may be transmitted between the CP 18 andthe IPG 14 via the telemetry circuitry 118 of the RC 16 (see FIG. 6).

Next, the ratio R between the cross-lead field potential measurementFP_(em)(E_(n)) and the intra-lead field potential measurementFP_(em)(E_(m±i)) is computed at step 206. Then, at step 208, theseparation distance d between the electrodes of the currently selectedcross-lead electrode pair [e_(m), E_(n)] is estimated by accessing thelook-up table, and obtaining the separation distance d corresponding tothe reference ratio R_(REF) that is closest in value to the measuredratio R. Notably, utilizing a field potential measurement ratio R, asopposed to utilizing an absolute field potential measurement, minimizesthe subject-to-subject variation or day-to-day variation (for a singlesubject) of tissue conductivities.

Next, at step 210, it is determined whether the separation distances dfor all of the cross-lead electrode pairs have been determined. If not,the process returns to steps 202-208 in order to estimate the separationdistance d between the electrodes of another cross-lead electrode pair,using the electrodes of another intra-lead pair as a reference. If theseparation distances d for all of the cross-lead electrode pairs havebeen determined, a lead model is fitted to the separation distances dwith respect to the longitudinal electrode positions at step 212. Whileany curve may be fit to the separation distance values d (including nofit), in a preferred embodiment, with a simple assumption of the lead asrelatively rigid and straight, a straight line can be fit to theseparation distance values d using a linear function.

Candidate fitting methods include, but are not limited to, curve fittingand regression. An alternative embodiment can fit a simple curve to theplotted separation distance values d. This may be clinically meaningful,since percutaneous leads are often not rigid and straight, and may curvewithin the body space. A simple curve applied to the plotted separationdistance values d may be used to represent this physical reality. Anexemplary set of cross-lead separation distances values d and a fittedstraight line lead model is illustrated in FIG. 12. As there shown, amodel of lead electrodes (represented by squares) arranged in a straightline is fitted to plotted separation distance values d (represented bycircles). Notably, the fitting process may balance out the variance inthe estimation of the pair-wise cross-lead electrode separationdistances d. Reciprocal measurements (e.g., using electrode E11 as anactivating electrode, electrode E4 as a cross-lead field potentialmeasurement electrode, and E12 or E10 as an intra-lead field potentialmeasurement electrode) can be used to increase the confidence of thefitting process.

Once the lead model is fitted to the cross-lead electrode separationdistance values d, the relative positioning (e.g., the distance betweenthe leads and/or the angle between the leads) can be estimated at step214. As shown in FIG. 12, representations of first lead electrodes(represented by squares) are disposed vertically along a referencedistance of 0 mm, and representations of the second lead electrodes(represented by squares), which were fitted to the plotted separationdistances d, are longitudinally offset in the caudal direction relativeto the first lead electrodes. The distal tip of the second lead isseparated from the first lead by approximately 1 mm, and the bottom tipof the second lead is separated from the first lead by approximately 1.5mm, which provides dimensions that can be used to obtain the relativeangle between the leads using conventional geographical techniques.Notably, the quantitative information of the relative lead positionobtained at step 214 can also be used to refine the estimation of thelongitudinal offset between the leads.

This quantitative information can also be used to detect the retrogradecondition of one of the paired leads (i.e., when one lead is oriented inthe rostral direction while the other is oriented in caudal direction).For example, when such retrograde condition is unknown, one would assumethat, e.g., electrodes E1 and E9 are aligned (i.e., adjacent to eachother), so that the separation distance d estimated between them isreasonable. However, if one of the leads are actually retrograde, butthis condition is not detected (which could happen if one looks only atthe fluoroscopy image to determine the stagger), electrode El may beadjacent electrode E16, and electrode E9 is much further away fromelectrode E1, such that the distance estimated between electrodes El andE9 are unusually large, which may suggest a retrograde condition.

Additional processing, such as displaying the leads and their properpositioning relative to each other (e.g., on the 124 of the CP 18 (shownin FIG. 3), can be performed at step 216, so that the user may eitherreposition the leads or appropriately program the IPG 14 taking intoaccount the relative positioning. Thus, it can be appreciated thatbecause this method is electric field based and automatic, it canpotentially reduce or minimize the need for fluoroscopy. In the casewhere more than two leads are used (e.g., in a tri-lead arrangement),such additional processing can further include using the pair-wise leadseparation to distinguish the middle and lateral leads from each other.

That is, since the separation between two lateral leads would be greaterthan that between a middle lead and a lateral lead, or that between twomiddle leads, a relatively large separation distance d between two leadswould indicate that these two leads are lateral leads, with theremaining lead being determined as the middle lead by the process ofelimination. In this case, the CP 18 may be configured for remapping theoutputs (i.e., the ports) of the analog output circuitry 60 (shown inFIG. 4) to the proper electrodes 26 of the stimulation lead or leads 12by transmitting appropriate control data to the IPG 14. Once the middlelead 12 is identified and the outputs of the analog output circuitry 60are mapped to the electrodes 26, the CP 18 can then generate stimulationparameters for use by the IPG 14. Thus, the user may insert each lead 12into any port 44 of the connector 42 of the IPG 14 without concern thatthe incorrect connector port is being used.

While the present inventions contemplate that the CP 18 may, itself,process or analyze the measured field potential information in order toeffect determination of the relative positioning of multiple leads, aswell as to effect the identification of the leads in a tri-polar leadarrangement, the IPG 14 or the RC 16 may optionally have thiscapability. If the IPG 14, alone, performs these functions, it maymodify its own programming and remap its own ports without communicationwith the CP 18 or the RC 16. In this case, the RC 16 and/or CP 18 mayconventionally operate with respect to the IPG 14.

As previously stated, other electrical parameters besides fieldpotential can be used to estimate the cross-lead separation distances.For example, a cross-lead bipolar impedance measurement and a referenceintra-lead bipolar impedance measurement can be taken (using anelectrode pair as an anode and a cathode and applying a constant currentto take an impedance measurement on one of the electrodes). The measuredimpedance will be proportionate to the field potential drop between theelectrode pair. The larger the bipolar impedance is, the larger thedistance between the electrode pair.

Although particular embodiments of the present inventions have beenshown and described, it will be understood that it is not intended tolimit the present inventions to the preferred embodiments, and it willbe obvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present inventions. Thus, the present inventions are intended tocover alternatives, modifications, and equivalents, which may beincluded within the spirit and scope of the present inventions asdefined by the claims.

What is claimed is:
 1. A method of operating two leads disposed adjacenttissue of a patient, the method comprising: activating a first one of apair of electrodes respectively carried by the two leads to generate anelectrical field within the tissue; measuring an electrical parameter inresponse to the generated electrical field at a second one of the pairof electrodes; measuring a reference electrical parameter in response tothe generated electrical field at a reference electrode carried by thesame one of the two leads that carries the first electrode, wherein areference distance between the first electrode and the referenceelectrode is known prior to the generation of the electrical field;computing a ratio between the measured electrical parameter and themeasured reference electrical parameter; and computing a distancebetween the pair of electrodes as a function of the computed ratio andthe reference distance.